Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Halo Pharmaceutical, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for f...
Halo Pharmaceutical, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 7, 2020. Such persons may also file a written request for a hearing on the application on or before December 7, 2020.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on September 3, 2020, Halo Pharmaceutical Inc, 30 North Jefferson Road, Whippany, New Jersey 07981, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled
substances
Drug codes
Schedule
Dihydromorphine
9145
I
Hydromorphone
9150
II
The company plans to manufacture Hydromorphone (9150) for distribution to its customers. Dihydromorphine (9145) is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. No other activity for these drug codes is authorized for this registration.
21 CFR 1301.33(a)